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Clinical Trials in Canada: Impact of Globalization. Ghislain Boudreau, PhD Director Medical Affairs and Clinical Research Pfizer Canada Inc. R&D in Canada. Leading development pharmaceutical companies have used Canada strategically to reinforce their global development capacity.

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Clinical trials in canada impact of globalization

Clinical Trials in Canada: Impact of Globalization

Ghislain Boudreau, PhD

Director Medical Affairs

and Clinical Research

Pfizer Canada Inc


R d in canada
R&D in Canada

  • Leading development pharmaceutical companies have used Canada strategically to reinforce their global development capacity.

  • As a pivotal country to many development programs, Canada’s contribution to R&D Clinical Research has often been larger than its direct commercial contribution.


R d expenditure in canada
R&D Expenditure in Canada

Applied research, represents approximately 62% of current R&D expenditure. Clinical trials accounted for 76.9% of applied research expenditure.

PMPRB Annual Report 2005; www.pmprb-cepmb.gc.ca/english/


Annual Drug Submission Performance Report 2006, TPD

www.hc-sc.gc.ca/dhp-mps/alt_formats/hpfb-dgpsa/pdf/prodpharma/tpd_dpt_annual_annuel_05_e.pdf


Current environment
Current Environment

  • Rising Costs of Development

  • Pressure on R+D Budgets

  • An Industry under Pressure

  • Limited Pool of Trained Investigators

  • Global Competition


Productivity challenge

# NCEs

60

40

20

0

Productivity Challenge

$35

Total R&D Investment ($Billions)

$30

$25

$20

$15

$10

$5

$0

2003

1970

1975

1980

1985

1990

1995

2000

Source: 2004 PhRMA Annual Survey, 2003/2004 PAREXEL’S Pharmaceutical Industry Sourcebook



Globalization1
Globalization

The landscape is changing and clinical trials starting now are becoming more and more global with increase activities in the new emerging economies in Eastern Europe, Latin America and South Asia

(Getz, K.A., Applied Clinical Trials, December 1, 2005).


Globalization of Clinical Trials

The Globalization of Clinical Trials: Where Are They Going and Why?:Ernst R. Berndt, et al., Drug Information Association June 19, 2007

Atlanta, Georgia


Decision to place a clinical trial
Decision to place a clinical trial

Research

Balance

Cost

Speed

Quality


Global Trial Placement

Decision Making

Regulatory

Logistics

Disease

?

Training

Subjects

Infrastructure

Risk

Medical Practice



“if Canada is not successful in rewarding innovation, that innovation will be developed elsewhere”

(Russell Williams, President of Canada’s Research Based Pharmaceutical Companies (Rx&D), Statement – PMPRB Report 2005, Canada NewsWire, 23June 2006


The global context canada versus comparator countries
The Global Context; Canada versus Comparator Countries innovation will be developed elsewhere”

PMPRB Annual Report 2005; www.pmprb-cepmb.gc.ca/english


R d to sales ratio in canada
R&D-to-Sales Ratio in Canada innovation will be developed elsewhere”


Canada s contribution
Canada’s contribution innovation will be developed elsewhere”

  • One of the largest contributor in clinical trials investment after the US

  • Numerous advantages to conduct clinical trial in Canada:

    • Presence of Centres of Excellence;

    • Number of high quality clinical sites as measured by level of GCP training

    • Experienced clinical trial and site management organizations

    • Well-characterized patient populations

    • Early-stage initiatives to create centralized IRB

    • Cost advantage for biotech/biomedical R&D

Clinical Trials in Canada: Quality with Cost Advantage, Government of Canada, 2003)


Canada s contribution1
Canada’s contribution innovation will be developed elsewhere”

  • Numerous advantages to conduct clinical trial in Canada:

    • Lower diagnostic and interventional costs per patient through public healthcare

    • Financial support for clinical trials on a selective basis from government sources, e.g., Technology

    • Partnerships Canada (http://tpc.ic.gc.ca), Canadian Institutes of Health Research (CIHR) and BioLevier

    • Common standard-of-care which allows for easier integration of clinical trial data over many sites

    • Competitive labour costs, especially for research nurses with good clinical practice (GCP) training

      Canadian reputation for high standards of reliability in clinical research

Clinical Trials in Canada: Quality with Cost Advantage, Government of Canada, 2003)


Areas to explore
Areas to explore innovation will be developed elsewhere”

  • Streamlining clinical trials (moving away from empirical design)

  • Biomarker development

    • Genomic

    • Proteomic

    • New technology (imaging techniques…)

  • Collaboration with Biotech

  • Global Risk Management (Pharmacovigilance)

  • Partnership with Academia, Government, Scientific/Medical Associations


Canada a pivotal country
Canada – A pivotal country innovation will be developed elsewhere”

As a pivotal country to many development programs, Canada’s contribution to R&D has often been larger than its direct commercial contribution. In order to maintain this pace, we will need to work collaboratively at aiming to accelerate development of safe and effective medicines, aiming to bring tangible benefits to Canadian patients and revitalize the biopharmaceutical research environment.


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